Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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METALS LEVEL 1
UTAK LABORATORIES, INC.
MET T 1 WB UK
In Commercial Distribution

  • B80001696000011 ()
  • B80001696000010 ()
  • B80001696000012 ()
  • B80001696000013 ()
  • B80001696000016 ()
  • B80001696000017 ()
  • B80001696000018 ()


  • Multiple heavy metal IVD, control
No Description
UTAK LABORATORIES, INC.
U QC HIGH V2 EL
In Commercial Distribution

  • B80001390500040 ()
  • B80001390500041 ()
  • B80001390500042 ()
  • B80001390500043 ()
  • B80001390500046 ()
  • B80001390500047 ()
  • B80001390500048 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
U QC LOW V2 EL
In Commercial Distribution

  • B80001390500030 ()
  • B80001390500031 ()
  • B80001390500032 ()
  • B80001390500033 ()
  • B80001390500036 ()
  • B80001390500037 ()
  • B80001390500038 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
U QC HIGH EL
In Commercial Distribution

  • B80001390500021 ()
  • B80001390500020 ()
  • B80001390500022 ()
  • B80001390500023 ()
  • B80001390500026 ()
  • B80001390500027 ()
  • B80001390500028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
U QC LOW EL
In Commercial Distribution

  • B80001390500011 ()
  • B80001390500010 ()
  • B80001390500012 ()
  • B80001390500013 ()
  • B80001390500016 ()
  • B80001390500017 ()
  • B80001390500018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
7-AMINO PLUS 100 NG/ML
UTAK LABORATORIES, INC.
7-AMINO+ 100 MP
In Commercial Distribution

  • B80000357500031 ()
  • B80000357500030 ()
  • B80000357500032 ()
  • B80000357500033 ()
  • B80000357500036 ()
  • B80000357500037 ()
  • B80000357500038 ()


  • Benzodiazepine group IVD, control
DAU +25% GCMS
UTAK LABORATORIES, INC.
DAU +25 GCMS
In Commercial Distribution

  • B80000357500021 ()
  • B80000357500020 ()
  • B80000357500022 ()
  • B80000357500023 ()
  • B80000357500026 ()
  • B80000357500027 ()
  • B80000357500028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
DAU -25% GCMS
UTAK LABORATORIES, INC.
DAU -25 GCMS
In Commercial Distribution

  • B80000357500011 ()
  • B80000357500010 ()
  • B80000357500012 ()
  • B80000357500013 ()
  • B80000357500016 ()
  • B80000357500017 ()
  • B80000357500018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
MAC Charger
Recovery Force, LLC
B
In Commercial Distribution

  • B547RF14300 ()
  • B547RF1440237 ()
  • B547RF1440207 ()
  • B547RF1440217 ()
  • B547RF1440227 ()
  • B547RF143009 ()

  • Length: 203 Millimeter
RF1430

  • Intermittent venous compression system
Sterile syringe delivery device used to deliver (inject) Volumex (Iodinated I-131Allbumin injection) for use in determinations of total blood and plasma volumes.
DAXOR CORPORATION
MAX-100 Syringe
In Commercial Distribution

  • B641MAX1004 ()
  • B641MAX1002 ()
  • B641MAX1000 ()
  • B641MAX1003 ()
  • B641MAX1001 ()
  • B641MAX1005 ()


  • Metered-delivery hypodermic syringe
No Description
BIOTRICITY INC
1.0
In Commercial Distribution

  • B635BIOFLUX101 ()
  • B635BIOFLUX100 ()
  • B635BIOFLUX105 ()
  • B635BIOFLUX104 ()
  • B635BIOFLUX103 ()
  • B635BIOFLUX102 ()


  • Electrocardiography telemetric monitoring system transmitter
A sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.
NOVOSCI CORP.
201005NS
In Commercial Distribution

  • B066201005NS6 ()
  • B066201005NS1 ()
  • B066201005NS5 ()
  • B066201005NS4 ()
  • B066201005NS3 ()
  • B066201005NS2 ()
  • B066201005NS0 ()
201005NS

  • Body aspiration needle, single-use
A small, noninvasive, closed-ended Luer attachment intended to be attached to a luminal device (e.g., catheter, intravenous administration or pressure-monitoring tubing, syringe) with a Luer connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. This is a single-use device.
NOVOSCI CORP.
000325-011NS
In Commercial Distribution

  • B066000325011NS6 ()
  • B066000325011NS1 ()
  • B066000325011NS5 ()
  • B066000325011NS4 ()
  • B066000325011NS3 ()
  • B066000325011NS2 ()
  • B066000325011NS0 ()
000325-011NS

  • Luer-formatted protective cap
272 micrometer ScopeSafeâ„¢ Laser Fiber with SoftTipâ„¢
OPTICAL INTEGRITY INC
11613
In Commercial Distribution

  • B145116130 ()
  • B145116135 ()
  • B145116131 ()
  • B145116831 ()
  • B145116150 ()
  • B145116171 ()

  • Outer Diameter: 272 Micrometer
SU-200-ST

  • General/multiple surgical laser system beam guide, reusable
Light curing composite for the production of individual impression trays and base plates
MEGADENTA Dentalprodukte GmbH
2022/11/05
In Commercial Distribution

  • EMD11MYDVOKRS1 ()
  • EMD11MYDVOKS2 ()
  • EMD11MYDVOKBL1 ()
  • EMD11MYDVOKTR1 ()
  • EMD11MYDVOKRS11 ()


  • Dental impression tray material
The StaClear® Syringe is a single-use piston syringe consisting of a 0.25 mL graduated barrel, plunger, plunger gasket, needle, needle cap, and plunger cap. It is non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear® Syringe is suitable for ophthalmic use.
Staclear, Inc.
SC250AN
In Commercial Distribution

  • B994SC250AN0 ()
  • B994SC250AN2 ()
  • B994SC250AN6 ()
  • B994SC250AN8 ()
  • B994SC250AN4 ()

  • Total Volume: 0.25 Milliliter
  • Needle Gauge: 31 Gauge
  • Length: 8 Millimeter
SC250AN

  • General-purpose syringe/needle
The StaClear® Syringe is a single-use piston syringe consisting of a 0.25 mL graduated barrel, plunger, plunger gasket, needle, needle cap, and plunger cap. It is non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear® Syringe is suitable for ophthalmic use.
Staclear, Inc.
SC250
Not in Commercial Distribution

  • B994SC2501 ()
  • B994SC2500 ()
  • B994SC2503 ()
  • B994SC2505 ()
  • B994SC2502 ()

  • Total Volume: 0.25 Milliliter
  • Needle Gauge: 31 Gauge
  • Length: 8 Millimeter
SC250

  • General-purpose syringe/needle
MAC Controller
Recovery Force, LLC
H
In Commercial Distribution

  • B547RF14100 ()
  • B547RF144020 ()
  • B547RF144021 ()
  • B547RF144022 ()
  • B547RF1440230 ()

  • Length: 136 Millimeter
RF1410

  • Intermittent venous compression system
Biocompatible MRIaudio disposable ear-tip certified to 29dB NRR.
MRIAUDIO, INC.
302
In Commercial Distribution

  • B6693020 ()
  • B6693501 ()
  • B6693251 ()
  • B6693011 ()
  • B6693001 ()
302

  • Headphones
Vitale Silicone Super-Absorbent Dressings, 6" x 7", 10/box, 10 boxes/case, 2 cases/overpack
CELLERA LLC
20267
Not in Commercial Distribution

  • B492202673 ()
  • B492202671 ()
  • B492202670 ()
  • B492202672 ()
  • B49220673 ()
20267

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
ScanX Intraoral for Centralized Imaging is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose.
AIR TECHNIQUES, INC.
F3605
In Commercial Distribution

  • D678F36050 ()
  • D678F36001 ()
  • D678F3600U1 ()
  • D678F36051 ()
  • D678F3600C1 ()

  • Height: 16 Inch
  • Depth: 15.5 Inch
  • Width: 15.5 Inch
  • Weight: 44 Pound
F3600

  • Radiography digital imaging scanner
Individually packaged tampon
IMPACT PRODUCTS, LLC
251765
In Commercial Distribution

  • B34025160273 ()
  • B3402517650 ()
  • B34025176488 ()
  • B340A25176598 ()
  • B34025160275 ()


  • Menstrual tampon, unscented
Easy Glide 20cc Luer Lock Syringe
GLOBAL DIABETIC DISTRIBUTORS INC
672020
In Commercial Distribution

  • B2086720203 ()
  • B2086720201 ()
  • B2086720200 ()
  • B2086720204 ()
  • B2086720205 ()


  • General-purpose syringe, single-use
A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C490S
In Commercial Distribution

  • B066C490S3 ()
  • B066C490S0 ()
  • B066C490S6 ()
  • B066C490S5 ()
  • B066C490S4 ()
C490S

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C490B
In Commercial Distribution

  • B066C490B1 ()
  • B066C490B5 ()
  • B066C490B4 ()
  • B066C490B3 ()
  • B066C490B2 ()
  • B066C490B0 ()
C490B

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C485S
Not in Commercial Distribution

  • B066C485S6 ()
  • B066C485S0 ()
  • B066C485S5 ()
  • B066C485S4 ()
  • B066C485S3 ()
C485S

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C480S
In Commercial Distribution

  • B066C480S0 ()
  • B066C480S3 ()
  • B066C480S6 ()
  • B066C480S5 ()
  • B066C480S4 ()
C480S

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C480B
In Commercial Distribution

  • B066C480B1 ()
  • B066C480B5 ()
  • B066C480B4 ()
  • B066C480B3 ()
  • B066C480B2 ()
  • B066C480B0 ()
C480B

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C475S
Not in Commercial Distribution

  • B066C475S6 ()
  • B066C475S0 ()
  • B066C475S5 ()
  • B066C475S4 ()
  • B066C475S3 ()
C475S

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C470S
In Commercial Distribution

  • B066C470S0 ()
  • B066C470S6 ()
  • B066C470S5 ()
  • B066C470S4 ()
  • B066C470S3 ()
C470S

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C470B
In Commercial Distribution

  • B066C470B1 ()
  • B066C470B5 ()
  • B066C470B4 ()
  • B066C470B3 ()
  • B066C470B2 ()
  • B066C470B0 ()
C470B

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C465S
In Commercial Distribution

  • B066C465S0 ()
  • B066C465S3 ()
  • B066C465S6 ()
  • B066C465S5 ()
  • B066C465S4 ()
C465S

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C460S
In Commercial Distribution

  • B066C460S0 ()
  • B066C460S6 ()
  • B066C460S5 ()
  • B066C460S4 ()
  • B066C460S3 ()
C460S

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C460B
In Commercial Distribution

  • B066C460B1 ()
  • B066C460B5 ()
  • B066C460B3 ()
  • B066C460B2 ()
  • B066C460B0 ()
  • B066C4604 ()
C460B

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C445S
In Commercial Distribution

  • B066C445S0 ()
  • B066C445S6 ()
  • B066C445S5 ()
  • B066C445S4 ()
  • B066C445S3 ()
C445S

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C445B
In Commercial Distribution

  • B066C445B1 ()
  • B066C445B5 ()
  • B066C445B4 ()
  • B066C445B3 ()
  • B066C445B2 ()
  • B066C445B0 ()
C445B

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C440S
In Commercial Distribution

  • B066C440S0 ()
  • B066C440S6 ()
  • B066C440S5 ()
  • B066C440S4 ()
  • B066C440S3 ()
C440S

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C440B
In Commercial Distribution

  • B066C440B1 ()
  • B066C440B5 ()
  • B066C440B4 ()
  • B066C440B3 ()
  • B066C440B2 ()
  • B066C440B0 ()
C440B

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C435S
In Commercial Distribution

  • B066C435S0 ()
  • B066C435S6 ()
  • B066C435S5 ()
  • B066C435S4 ()
  • B066C435S3 ()
C435S

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C430S
In Commercial Distribution

  • B066C430S0 ()
  • B066C430S6 ()
  • B066C430S5 ()
  • B066C430S4 ()
  • B066C430S3 ()
C430S

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
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